Partner Katy Koski was quoted in a Pharmaceutical Technology article, “CREATES Act Dropped But May Still See Progress,” about the chances that legislation aimed at lowering the costs of prescription drugs will be taken up by Congress this year.
The legislation, formally known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, would prevent companies making branded drugs from refusing to sell samples to firms producing lower-cost generic and biosimilar versions, who need access to branded drugs to conduct the comparative testing required to get their own versions approved.
Koski said the focus on the sample-access issue has increased significantly with the introduction of biosimilars, whose manufacturers need to buy multiple batches of branded drugs from various manufacturing lots.
The legislation, formally known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, would prevent companies making branded drugs from refusing to sell samples to firms producing lower-cost generic and biosimilar versions, who need access to branded drugs to conduct the comparative testing required to get their own versions approved.
Koski said the focus on the sample-access issue has increased significantly with the introduction of biosimilars, whose manufacturers need to buy multiple batches of branded drugs from various manufacturing lots.
People
Related News
23 April 2024
In the News
David Sanders Discusses Lessons Learned from General Counsel Leadership Program
Foley & Lardner LLP partner David Sanders recently joined a panel discussion with members of The Vanguard Network’s General Counsels Advisory Group to discuss the evolving role of the general counsel.
23 April 2024
In the News
Claire Marblestone Discusses HHS Final Rule on Protected Health Information Disclosure
Foley & Lardner LLP Claire Marblestone assessed the U.S. Department of Health and Human Services’ final rule that bars providers, health plans, and other entities covered by the Health Insurance Portability and Accountability Act from disclosing protected health information in a Healthcare Dive article.
22 April 2024
In the News
Scott Ellis Comments on Big Law Recruiting Ramp Up – “Right out of the box, you’re looking at them as new hires”
Foley & Lardner LLP partner Scott Ellis offers insight on the rise of early recruitment by major law firms and its impact on law students in the Bloomberg Law article, “Big Law Skips Ahead of On-Campus Recruiting in Talent Race."